1 / 20

IN-SITU MONITORING OF QUALITY OF PHARMACEUTICAL PRODUCTS USING LASER BREAKDOWN SPECTROSCOPY

IN-SITU MONITORING OF QUALITY OF PHARMACEUTICAL PRODUCTS USING LASER BREAKDOWN SPECTROSCOPY. TOTAL QUALITY CONTROL (TQC ). CONVENTIONAL QUALITY CONTROL: End Product TOTAL QUALITY CONTROL: At every stage of the process FOR OTHER INDUSTRY TQC IS A BUSINESS TOOL

benjy
Download Presentation

IN-SITU MONITORING OF QUALITY OF PHARMACEUTICAL PRODUCTS USING LASER BREAKDOWN SPECTROSCOPY

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. IN-SITU MONITORING OF QUALITY OF PHARMACEUTICAL PRODUCTS USING LASER BREAKDOWN SPECTROSCOPY Presented at PITTCON 2003, March 9-14 Orlando Florida

  2. TOTAL QUALITY CONTROL (TQC) • CONVENTIONAL QUALITY CONTROL: End Product • TOTAL QUALITY CONTROL: At every stage of the process • FOR OTHER INDUSTRY TQC IS A BUSINESS TOOL • PHARMACEUTICAL INDUSTRYTQCIS LEGAL REQUIRMENT; USA FEDERAL FOOD, DRUG AND COSMETIC ACT Presented at PITTCON 2003, March 9-14 Orlando Florida

  3. TECHNIQUES • LISTED IN UNITED STATES PHARMACOPEIA • WET CHEMSITRY • IR,VIS,UV, ABSORPTION/FLUORESCENCE • SPECTROMETRY • LIGHT SCATTERING • MASS SPECTROMETRY • CHROMATOGRAPHY • NMR (CW/FTR) • X-RAY FLUORESCENCE/DIFFRACTION Presented at PITTCON 2003, March 9-14 Orlando Florida

  4. WHY NEW TECHNIQUE • All these techniques need sample preparation • Most of the operating costs and time are spent on the preparation of the sample for injection in the measurement device • Waste storage, segregation and disposal of chemicals/solvents • We need a technique which needs no sample preparation Presented at PITTCON 2003, March 9-14 Orlando Florida

  5. LASER INDUCED BREAKDOWN SPECTROSCOPY(LIBS) • Almost no sample preparation • Several elements can be monitored simultaneously • Results are available almost immediately • Optical fibers make it more convenient Presented at PITTCON 2003, March 9-14 Orlando Florida

  6. PROBLEMS WITH LIBS • Process involved • ablation, atomization and excitation are complex and difficult to reproduce • Careful optimization of experimental parameters to achieve detection limits and accuracy better /comparable with the alternate techniques Presented at PITTCON 2003, March 9-14 Orlando Florida

  7. SAMPLES • . • wt% inwt% inwt% inwt% in • Amount of brand Abrand Bbrand Cbrand D • 99.99% • CaCO3 • Ca NaCaCa MgCa • 10 tablets+0g 14.20 0.2515.8015.10 3.1218.53 • 10 tablets+1.00g 15.43 0.2417.6216.02 2.8820.09 • 10 tablets+2.00g 16.54 0.2319.1917.59 2.8021.43 • 10 tablets+3.00g 17.56 0.22 20.5518.29 2.6222.66 • 10 tablets+4.00g 18.48 0.21 21.7419.51 2.5324.85 • 10 tablets+5.00g 19.36 0.20 22.8420.24 2.4025.58 Presented at PITTCON 2003, March 9-14 Orlando Florida

  8. EXPERIMENTAL SETUP Presented at PITTCON 2003, March 9-14 Orlando Florida

  9. OPTIMIZATION OF FOCAL SPOT Presented at PITTCON 2003, March 9-14 Orlando Florida

  10. DELAY TIME Presented at PITTCON 2003, March 9-14 Orlando Florida

  11. SAMPLE ROTATION Presented at PITTCON 2003, March 9-14 Orlando Florida

  12. Absolute Intensity • Iji = nX(hc/lji){gj/Q(T)}Aji Exp[-Ej/kT] • Or • Iji = nXK • Which is a linear relation Presented at PITTCON 2003, March 9-14 Orlando Florida

  13. INTENSITY RATIO • (Iji)x = nX(hc/lji)x[{gj/Q(T)}Aji]x Exp[-Ej/kT]x • (Imn)y=nY(hc/lmn)Y[{gm/Q(T)}Amn]Y Exp[-Em/kT]Y • Temperature dependence of Q is neglected • T(x) =T(Y) ~Te • [(Iji)x]/[(Imn)y= constant[nX/nY] Presented at PITTCON 2003, March 9-14 Orlando Florida

  14. LIBS SPECTRUM IN 380-400 nm REGION Presented at PITTCON 2003, March 9-14 Orlando Florida

  15. LIBS SPECTRUM IN 320-340 nm REGION Presented at PITTCON 2003, March 9-14 Orlando Florida

  16. CALIBRATION FOR ACTIVE INGREDIENT Ca Presented at PITTCON 2003, March 9-14 Orlando Florida

  17. CALIBRATION FOR ACTIVE INGREDIENT Mg Presented at PITTCON 2003, March 9-14 Orlando Florida

  18. CALIBRATION FOR IN-ACTIVE INGREDIENT Na Presented at PITTCON 2003, March 9-14 Orlando Florida

  19. CALIBRATION FOR IMPURITY Al Presented at PITTCON 2003, March 9-14 Orlando Florida

  20. CONCLUSIONS • LIBS CAN BE USED IN TQC TO: • SIMULTANEOUSLY MONITOR ON-LINE • 1. ACTIVE INGREDIENTS • 2. INACTIVE INGREDIENTS • 3. IMPURITIES • OF PHARMACEUTICAL PRODUCTS Presented at PITTCON 2003, March 9-14 Orlando Florida

More Related